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Phensedyl

DRY COUGH LINCTUS

 

PRESENTATION

Phensedyl Dry Cough Linctus is presented as a bright, or almost bright, dark golden-brown liquid with a banana odour.

Each 5 ml contains:

   Promethazine hydrochloride 3.6mg

   Pholcodine 5mg

   Pseudoephedrine hydrochloride 20mg

in a flavoured vehicle.

 

It also contains sugars 66% w/v, sodium benzoate 0.1% w/v, sodium sulphite 0.1% w/v and sodium metabisulphite 0.1% w/v, ethanol 4% v/v.

 

INDICATIONS

An aid in the suppression of dry irritating coughs day and night.

 

DOSAGE AND ADMINISTRATION

To be taken undiluted two or three times daily.

Children:

   Under 2 years : Not recommended

   2 to 5 years : 2.5ml

   5 to 10 years : 2.5ml to 5ml

   Over 10 years : 5ml to 10ml

Adults: 5ml to 10ml

 

CONTRAINDICATIONS

Phensedyl should not be given concurrently with, or for two weeks after, treatment with MAOIs, as this may cause hypertensive effects. Contraindicated in individuals known to be hypersensitive to pholcodine, promethazine or pseudoephedrine. Contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma and in patients with liver disease.

 

Use in Pregnancy

Do not use during pregnancy without medical advice. When given in high doses during late pregnancy, phenothiazines have caused prolonged extrapyramidal disturbances in the child.

 

PRECAUTIONS

This product should not be used in children under 2 years of age, because safety of such use has not been established.

 

Phensedyl contains metabisulphite, a sulphite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulphite sensitivity in the general population is unknown and probably low. Sulphite sensitivity is seen more frequently in asthmatic than nonasthmatic people.

 

This preparation may cause drowsiness. If affected, do not drive or operate machinery.

 

Interactions

Alcohol or other CNS depressants may lead to greater drowsiness and sedation. If pholcodine is taken within two weeks of MAOI therapy, CNS excitation may occur.

 

SIDE EFFECTS

Drowsiness may occur initially in some patients. Initial doses should be small for those in charge of vehicles or machinery until it is evident that any soporific effect has not materialized or has subsided. Other side effects include nausea, vomiting, constipation, sedation, blurred vision, dryness of mouth, dizziness, increased or decreased blood pressure and rash.

 

PHARMACOLOGY

Pharmacodynamics

Promethazine HCI exerts its major effects by antagonizing the histamine H1-receptors on the effector cell to the exclusion of agonist molecules. The action is competitive and reversible.

 

Pholcodine is a cough suppressant which has a central action on the cough centre in the medulla. Although structurally related to morphine, pholcodine has no analgesic properties and in general it has little sedative activity. Unlike codeine, there is little or no metabolism of pholcodine to morphine and this may contribute to its lack of analgesic activity, morphine-like side-effects, and addictive potential.

 

Pseudoephedrine HCI is a sympathomimetic agent with direct and indirect effects on adrenergic receptors. Pseudoephedrine is a stereoisomer of ephedrine and has a similar action, but has been stated to have less pressor activity and central nervous system effects.

 

Pharmacokinetic

Promethazine is well absorbed after oral administration. Peak plasma concentrations have been observed 2 to 3 hours after administration, although there is a low systemic bioavailability after oral administration, due to high first-pass metabolism in the liver. Promethazine is widely distributed; it enters the brain and crosses the placenta. Values ranging from 76 to 92% have been reported for plasma protein binding. Promethazine undergoes extensive metabolism, predominantly to promethazine sulphoxide, and also to N-desmethylpromethazine. It is excreted slowly via the urine and bile, chiefly as metabolites. Elimination half-lives of 5 to 14 hours have been reported.

 

Pholcodine is readily absorbed from the gastrointestinal tract and does cross the blood-brain barrier. It is metabolized in the liver and its action may be prolonged in hepatic insufficiency.

 

Pseudopehedrine is absorbed from the gastro-intestinal tract. It is resistant to metabolism by monoamine oxidase and is largely excreted unchanged in the urine together with small amounts of its hepatic metabolite. It has a half-life of several hours; elimination is enhanced and half-life accordingly shorter in acid urine.

 

TREATMENT OF OVERDOSAGE

Symptoms of overdosage with Phensedyl are variable. They are characterized in children by various combinations of excitation, ataxia, incoordination, athetosis and hallucinations, while adults may become drowsy and lapse into coma. Convulsions, may occur in both adults and children, coma may precede their occurrence. Tachycardia may develop. Cardiorespiratory depression is not uncommon. If the patient is seen soon after ingestion, it should be possible to induce vomiting with ipecacuanha despite the antiemetic effect of promethazine; alternatively, gastric lavage may be used. Use of charcoal and purgatives may help in other cases. Treatment is otherwise supportive with attention to maintenance of adequate respiratory and circulatory status. Convulsions should be treated with diazepam or other suitable convulsant. Use of naloxone should be considered if respiratory or central depression dominate the clinical features.

 

STORAGE CONDITIONS

Store below 25C. Protect from light.

 

SHELF-LIFE

Respect expiry date as indicated on packaging.

 

PACKAGING AND PACK SIZE

Bottles of 90ml.

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